GSK1059615 Clinical Trials

Size	Price	Qty
10mg	USD 380
50mg	USD 970

Clinical Trials

GlaxoSmithKline sponsored multiple Phase 1 clinical trials to evaluate the safety, pharmacokinetics, and preliminary therapeutic activity of GSK1059615 in patients with advanced solid tumors and lymphoma. However, recruitment across these early-stage, dose-escalation studies was terminated, indicating that clinical development by the sponsor was discontinued. Consequently, available data for GSK1059615 remains limited to these terminated Phase 1 evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00695448	TERMINATED	Solid Tumours	GlaxoSmithKline	2008-06-24	PHASE1
NCT00695448	Terminated	Solid Tumours	GlaxoSmithKline	2008-06-24	Phase 1

(data from https://clinicaltrials.gov, updated on 2017-07-25)

Check the GSK1059615 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK1059615 reversibly binds to class I phosphoinositide 3-kinase (PI3K) isoforms α, β, δ, and γ as well as mTOR, thereby suppressing downstream AKT signaling and nutrient-sensing biochemical cascades. This dual pathway blockade induces G1 phase cell cycle arrest and inhibits cancer cell proliferation, providing the mechanistic rationale for its clinical investigation in solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).